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HSA Approval

AERIUS TABLET 5 mg

SIN11743P

AERIUS TABLET 5 mg

AERIUS TABLET 5 mg

December 26, 2001

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Regulatory Information

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Therapeutic

Pharmacy Only

Formulation Information

TABLET, FILM COATED

DOSAGE AND ADMINISTRATION: Adults and Adolescents (12 years of age and older): For oral use. One AERIUS 5 mg film-coated tablet once a day, regardless of mealtimes, and as and when necessary, for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria. Desloratadine is not recommended for long-term use. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods.

ORAL

Medical Information

INDICATIONS AND USAGE: AERIUS Tablets are indicated for the rapid relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. AERIUS Tablets are also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives.

CONTRAINDICATIONS: Hypersensitivity to the desloratadine, loratadine or to any of the excipients.

R06AX27

desloratadine

Manufacturer Information

ORGANON SINGAPORE PTE. LTD.

Organon Heist bv

Active Ingredients

DESLORATADINE

5 mg

Desloratadine

Documents

Package Inserts

Aerius Tablet PI.pdf

Approved: March 20, 2023

Download

Patient Information Leaflets

Aerius Tablet PIL.pdf

Approved: March 20, 2023

Download

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AERIUS TABLET 5 mg - HSA Approval | MedPath